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A Caregiver-mediated Intervention Improves the Functional Ability of Home-living Chronic Stroke Patients

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Care-giver mediated training
Sponsored by
Asia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stroke focused on measuring Chronic stroke patients, Stroke rehabilitation, Caregiver, Caregiver-mediated intervention

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. >6 months post first stroke with mild to moderate disability (Brunnstrom stage III-V)
  2. No longer undertaking active rehabilitation program(defined as ≤2 times/wk rehabilitation activities)

Exclusion Criteria:

  1. Recurring strokes
  2. Mental or cognitive impairment
  3. Severe orthopedic disability or unstable medical conditions (such as severe rheumatoid arthritis or acute myocardial infarction)
  4. Caregiver with mental/behavioral disorders

Sites / Locations

  • St. Joseph Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Care-giver mediated training

Standard-care

Arm Description

Each patient and the caregiver of the intervention group received weekly home training and exercise counseling by a physical therapist about the caregiver mediated home exercise skill for stroke patient. The training program were progress weekly based on the patient's need.

Maintain the inherent standard-care

Outcomes

Primary Outcome Measures

Stroke Impact Scale
Change from baseline in Stroke Impact Scale at 12 weeks

Secondary Outcome Measures

10-meter walking speed
Change from baseline in 10-meter walking speed (cm/sec) at 12 weeks
Berg balance scale
Change from baseline in berg balance scale score at 12 weeks
6-min walking distance
Change from baseline in 6-min walking distance at 12 weeks
Bathel index score
Change from baseline in Bathel index score at 12 weeks
Lawton Instrumental Activities of Daily Living scale (IADL)
Change from baseline in Lawton Instrumental Activities of Daily Living Scale at 12 weeks
Fugl-Meyer Assessment Scale
Change frome baseline in Fugl-Meyer Assessment Scale score at 12 weeks

Full Information

First Posted
September 20, 2012
Last Updated
March 28, 2013
Sponsor
Asia University
Collaborators
National Science Council, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT01693341
Brief Title
A Caregiver-mediated Intervention Improves the Functional Ability of Home-living Chronic Stroke Patients
Official Title
Caregiver-mediated Intervention in Home-living Chronic Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asia University
Collaborators
National Science Council, Taiwan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To examine the feasibility of improving stroke patients' physical functional recovery and social participation through improving caregiver's care capability.
Detailed Description
In the hospital, most rehabilitation units are like sheltered workshops and the therapists work with stroke patients in well-designed, but non-home-like, environment to improve the stroke patient's functional ability. After returning home, stroke patients face new challenges and also need to assume more responsibility for daily activities. Without continuing rehabilitation training or proper support, the patients can easily fall into a sedentary lifestyle and lead to declines in functional ability.However, providing home-based exercise by therapists directly would increase the health care cost and may not be practical for chronic stroke patients. Hence, the objective of the present study was to determine whether a caregiver-mediated, home-based intervention program is effective for improving stroke patients' functional ability and social participation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Chronic stroke patients, Stroke rehabilitation, Caregiver, Caregiver-mediated intervention

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Care-giver mediated training
Arm Type
Active Comparator
Arm Description
Each patient and the caregiver of the intervention group received weekly home training and exercise counseling by a physical therapist about the caregiver mediated home exercise skill for stroke patient. The training program were progress weekly based on the patient's need.
Arm Title
Standard-care
Arm Type
No Intervention
Arm Description
Maintain the inherent standard-care
Intervention Type
Other
Intervention Name(s)
Care-giver mediated training
Intervention Description
A physical therapist visited each subject and the caregiver (of the intervention group) once weekly for about 90 min/session to teach patient-skills and caregiver-skills. The therapist first reviewed the condition of each patient and planned patient-specific training programs, continuously performed 12 weeks.
Primary Outcome Measure Information:
Title
Stroke Impact Scale
Description
Change from baseline in Stroke Impact Scale at 12 weeks
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
10-meter walking speed
Description
Change from baseline in 10-meter walking speed (cm/sec) at 12 weeks
Time Frame
Baseline and 12 weeks
Title
Berg balance scale
Description
Change from baseline in berg balance scale score at 12 weeks
Time Frame
Baseline and 12 weeks
Title
6-min walking distance
Description
Change from baseline in 6-min walking distance at 12 weeks
Time Frame
Baseline and 12 weeks
Title
Bathel index score
Description
Change from baseline in Bathel index score at 12 weeks
Time Frame
Baseline and 12 weeks
Title
Lawton Instrumental Activities of Daily Living scale (IADL)
Description
Change from baseline in Lawton Instrumental Activities of Daily Living Scale at 12 weeks
Time Frame
Baseline and 12 weeks
Title
Fugl-Meyer Assessment Scale
Description
Change frome baseline in Fugl-Meyer Assessment Scale score at 12 weeks
Time Frame
Baseline and 12 weeks
Other Pre-specified Outcome Measures:
Title
Center for Epidemiologic Studies Depression Scale
Description
Change from baseline in Center for Epidemiologic Studies Depression Scale score at 12 weeks
Time Frame
Baseline and 12 weeks
Title
Caregiver Burden Scale
Description
Change from baseline in Caregiver Burden Scale at 12 weeks
Time Frame
baseline and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: >6 months post first stroke with mild to moderate disability (Brunnstrom stage III-V) No longer undertaking active rehabilitation program(defined as ≤2 times/wk rehabilitation activities) Exclusion Criteria: Recurring strokes Mental or cognitive impairment Severe orthopedic disability or unstable medical conditions (such as severe rheumatoid arthritis or acute myocardial infarction) Caregiver with mental/behavioral disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan. C Tsai, PhD
Organizational Affiliation
Asia University
Official's Role
Study Chair
Facility Information:
Facility Name
St. Joseph Hospital
City
Kaohsiung
ZIP/Postal Code
80288
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
21233462
Citation
Galvin R, Cusack T, O'Grady E, Murphy TB, Stokes E. Family-mediated exercise intervention (FAME): evaluation of a novel form of exercise delivery after stroke. Stroke. 2011 Mar;42(3):681-6. doi: 10.1161/STROKEAHA.110.594689. Epub 2011 Jan 13.
Results Reference
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A Caregiver-mediated Intervention Improves the Functional Ability of Home-living Chronic Stroke Patients

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